Milestones & News

University Hospital Is First in Suffolk County Selected for New FDA-Approved Procedure

STONY BROOK, NY, December 12, 2012 — Stony Brook University Hospital has become the first hospital in Suffolk County to offer a new FDA-approved procedure to treat severe aortic stenosis by replacing the aortic valve with a prosthetic valve, without the need for open-heart surgery.

The first procedure, called transcatheter aortic valve replacement, or TAVR, was performed at Stony Brook Heart Institute on November 21. The new procedure offers hope for patients with severe symptomatic aortic stenosis, which can be life-threatening if not treated. Studies indicate that 50% of patients will not survive more than an average of two years after the onset of symptoms.

The procedure is being performed at Stony Brook by a team of cardiologists and cardiothoracic surgeons, consisting of:

James R. Taylor Jr., MD, FACS, FACC, professor of surgery at Stony Brook University School of Medicine, chief of the Division of Cardiothoracic Surgery and co-director of the Stony Brook University Heart Institute.

Harold A. Fernandez, MD, FACS, professor of Surgery at the Stony Brook University School of Medicine, deputy chief of the Division of Cardiothoracic Surgery and co-director of the Heart Institute.

Smadar Kort, MD, FACC, FASE, professor of medicine at Stony Brook University School of Medicine and director of the Heart Institute's Valve Center.

Allen Jeremias, MD, MSc, FACC, associate professor of medicine at Stony Brook University School of Medicine and director of the Coronary Intensive Care Unit and the Cardiac Acute Care Unit at Stony Brook University Hospital.

Approximately 500,000 patients nationwide suffer from severe aortic stenosis, but only half of those patients have symptoms of the disease. Patients can develop debilitating symptoms that can restrict normal day-to-day activities, such as walking short distances or climbing stairs. For patients with symptoms, aortic valve replacement (AVR) is the only effective, long-term treatment option to prevent or delay their disease progression, Dr. Taylor said.

As Long Island's only university-based cardiovascular program, Stony Brook University Heart Institute is the region's leading referral center for clinically complex cardiac care. It offers a comprehensive, multidisciplinary program for the prevention, diagnosis and treatment of cardiovascular disease, including Suffolk County's only university-based open-heart surgery program and 24/7 interventional services.

The TAVR procedure will be offered at the Heart Institute's Valve Center, which opened in September 2011 and is the only center of its type on Long Island. The FDA approved the procedure in November 2011 for patients who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis, said Dr. Kort, director of the Valve Center. The new transcatheter procedure allows the diseased native heart valve to be replaced without open-heart surgery, while the heart is still beating.

"Without an aortic valve replacement, half of these patients (with severe symptomatic aortic stenosis) will not survive more than an average of two years after the onset of their symptoms," Dr. Kort said. "That's what makes this new treatment option so vital. It literally will make a life-or-death difference for many of these patients."

Data from a recent clinical trial demonstrated two year all-cause mortality rate of 34% in patients receiving the valve replacement procedure, Dr. Taylor said. "One-year survival rates were equivalent to that for similarly high-risk surgery patients," he said. As with most therapies, there are risks associated with the procedure, he added. It is a procedure involving general anesthesia, and placement of the valve is associated with specific contraindications as well as serious adverse effects, including risks of death, stroke, bleeding and vascular complications.

In the procedure, a balloon-expandable valve is delivered via catheter without a sternotomy or cardiopulmonary bypass, Dr. Taylor said. The Heart Institute's treatment team, which includes a cardiothoracic surgeon, interventional cardiologist, echocardiographer, anesthesiologist, and pre- and post-operative care providers, takes a rigorous, multi-disciplinary approach to patient care to ensure appropriate patient selection and optimal outcomes. The average recovery period for patients is one to two weeks.

Surgical aortic valve replacement is the "gold standard" and an effective treatment of severe aortic stenosis, Dr. Fernandez said. It has been proven to provide symptomatic relief and long-term survival in adults. During the surgical valve replacement procedure, the damaged "native" heart valve is removed and replaced with a prosthetic valve. Surgical aortic valve replacement is recommended for virtually all adult patients who do not have other serious medical conditions.

Up to 1.5 million people in the United States suffer from aortic stenosis, a progressive disease that affects the aortic valve of their hearts. It occurs most typically in patients ages 75 or older. It can also occur as a result of congenital heart defects, rheumatic fever, radiation therapy, medication or inflammation of the membrane of the heart. Symptoms of aortic stenosis include:

Severe shortness of breath leading to gasping — even at rest

Chest pain or tightness

Fainting

Extreme fatigue

Lightheadedness/dizziness

Difficulty exercising

Rapid or irregular heartbeat

Severe aortic stenosis causes narrowing or obstruction of the aortic valve and is most often due to accumulations of calcium deposits on the valve's leaflets (flaps of tissue that open and close to regulate the flow of blood in one direction through the valve). The resulting stenosis (narrowing of the passage) impairs the valve's ability to open and close properly. When the leaflets don't fully open, the heart works harder to push blood through the calcified aortic valve. Eventually, the heart's muscles weaken, increasing the risk of heart failure. Echocardiography is the diagnostic test of choice.